NCT07611747 Carotid Ultrasound-Based Strategy for Primary Prevention of Cardiovascular Events in Inflammatory Rheumatic Disease (PREVENER)
| NCT ID | NCT07611747 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Instituto de Investigación Marqués de Valdecilla |
| Condition | Rheumatoid Arthritis (RA) |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,944 participants |
| Start Date | 2026-04-22 |
| Primary Completion | 2031-04-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 1,944 participants in total. It began in 2026-04-22 with a primary completion date of 2031-04-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
PREVENER is a randomized, open-label, multicenter, phase IV clinical trial designed to evaluate the efficacy and safety of a carotid ultrasound-based strategy for the primary prevention of cardiovascular events in patients with inflammatory rheumatic diseases (IRD). Patients with IRD, including rheumatoid arthritis (RA), psoriatic arthritis (PsA), axial spondyloarthritis (AxSpA), and systemic lupus erythematosus (SLE), have a 50% higher risk of cardiovascular (CV) events compared to the general population. However, conventional CV risk scores (SCORE2/OP) systematically underestimate this risk, leaving many high-risk patients without appropriate preventive treatment. Patients aged ≥50 years with IRD and low-to-moderate CV risk according to SCORE2/OP will be randomized 1:1 to either an experimental group (carotid ultrasound to detect subclinical atherosclerosis) or a control group (standard care according to ESC 2021 guidelines). Patients in the experimental group with carotid plaques will be reclassified as very high CV risk and treated with high-intensity statins (LDL target \<55 mg/dL). The primary endpoint is the incidence of major adverse cardiovascular events (MACE) over 48 months of follow-up.
Eligibility Criteria
Inclusion Criteria: 1. Patients aged ≥50 years who have provided written informed consent. 2. Fulfillment of classification criteria for at least one of the following inflammatory rheumatic diseases: * Rheumatoid arthritis (RA) according to ACR/EULAR 2010 criteria * Psoriatic arthritis (PsA) according to CASPAR criteria * Axial spondyloarthritis (AxSpA) according to ASAS criteria * Systemic lupus erythematosus (SLE) according to ACR/EULAR 2019 criteria 3. Low-to-moderate cardiovascular risk according to SCORE2/OP classification. Exclusion Criteria: 1. Presence of previous cardiovascular events, type 2 diabetes mellitus, familial hypercholesterolemia, or chronic kidney disease resulting in classification as high or very high cardiovascular risk. 2. Prior carotid ultrasound examination with subsequent therapeutic intervention derived from its results, either in the context of a research study or routine clinical practice. 3. Contraindications to lipid-lowering therapy, including recent history of alcoholism, active liver disease, or unexplained and persistent elevation of serum transaminases exceeding three times the upper limit of normal (applicable to statins and ezetimibe).
Frequently Asked Questions
Who can join the NCT07611747 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Rheumatoid Arthritis (RA). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07611747 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07611747 currently recruiting?
Yes, NCT07611747 is actively recruiting participants. Visit ClinicalTrials.gov or contact Instituto de Investigación Marqués de Valdecilla to inquire about joining.
Where is the NCT07611747 trial being conducted?
This trial is being conducted at Alicante, Spain, Elche, Spain, Orihuela, Spain, Barcelona, Spain and 11 additional locations.
Who is sponsoring the NCT07611747 clinical trial?
NCT07611747 is sponsored by Instituto de Investigación Marqués de Valdecilla. The trial plans to enroll 1,944 participants.
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